Treatment with Tysabri (natalizumab) can improve mental and social health in people with multiple sclerosis (MS), according to new data presented at the 2021 virtual American Academy of Neurology annual meeting (AANAM).
Tysabri, by Biogen, is an approved treatment for relapsing forms of MS, and works by blocking inflammatory immune cells from getting into the brain. In clinical trials, Tysabri has been demonstrated to lower the rate of MS relapses and to ease symptoms. Treatment with Tysabri also has been associated with improvements in health-related quality of life, fatigue, depression, and cognitive function.
According to Carrie Hersh, a neurologist and an assistant professor at Cleveland Clinic, some patients treated with Tysabri report a “feel-good effect” that isn’t seen with other MS therapies.
While this effect is commonly recognized, “its physiological basis and clinical characterization are not well-understood,” Hersh said.
To better understand the patient experience with Tysabri treatment, Hersh and colleagues from Biogen and other institutions conducted an analysis using real-world data. Their results were presented in a poster, titled “Impact of Natalizumab on Quality of Life in a Real-World Cohort of Patients With Multiple Sclerosis: Results from MS Partners Advancing Technology and Health Solutions (MS PATHS),” at AANAM, which was held online April 17-22.
The team analyzed data from a large database of real-world data called MS Partners Advancing Technology and Health Solutions, or MS PATHS. The researchers identified data for 164 Tysabri-treated patients.
The patients’ experiences were assessed with the Quality of Life in Neurological Disorders questionnaire, or Neuro-QoL, which assesses quality of life across 12 subject areas or domains, such as sleep disturbance, anxiety, fatigue, depression, and participation in daily activities.
Among all of the Tysabri-treated patients, scores on eight of the 12 domains significantly improved after starting treatment with the medication. When assessing only those individuals whose scores had been abnormally poor prior to treatment, improvements were seen in 10 of the 12 domains.
For all but two domains, more Tysabri-treated patients reported improvements of five or more points than reported worsening of at least five points. For the two exceptions — lower limb or leg function and participation in social roles and activities — a similar proportion experienced improvement or worsening.
“[Tysabri] can lead to clinically meaningful improvements in aspects of mental and social health,” Hersh concluded.
“These data show that the benefits Tysabri provides in terms of a patient’s quality of life are substantial,” Maha Radhakrishnan, MD, chief medical officer at Biogen, said in a press release.
In additional analyses, the researchers compared changes in Neuro-QoL scores with Tysabri with those seen with Roche’s Ocrevus (ocrelizumab), another MS treatment. These analyses used data from a subset of patients who received different treatments, but were otherwise similar.
In these analyses, Tysabri treatment led to significant improvements in 10 of 12 Neuro-QoL domains, as compared with 8 of 12 domains with Ocrevus. For all but one of the dozen domains, the rate of improvement was higher with Tysabri than with Ocrevus. However, only three of those domains reached significant differences for both groups: satisfaction with social roles and activities, participation in social roles and activities, and emotional and behavioral dyscontrol. Dyscontrol is an impaired ability to regulate emotion or behavior that can lead to difficulty resisting impulses.
Since greater improvements were seen with one MS therapy than the other — even though both are known to be effective — Hersh said that this difference is unlikely to be attributable to expectation bias, which occurs when people feel better because they are expecting that a medication will help.
“With chronic conditions like MS, where every patient has a different experience with the disease, it is critically important to understand how treatment impacts their daily living and quality of life,” said Radhakrishnan.
Tysabri is typically given every four weeks, or about once per month, but emerging research is suggesting that dosing less frequently — every six weeks — could reduce the risk of adverse effects, without diminishing efficacy. Two other Biogen posters at AANAM reported on this kind of less frequent dosing, referred to as extended-interval dosing or EID.
In one poster, “No difference in radiologic outcomes for natalizumab patients on extended interval dosing compared with standard interval dosing in MS PATHS,” researchers used data from independent real-world studies to compare brain damage, assessed via MRI scan, with standard dosing or EID.
The analysis, which included 327 patients who received Tysabri via standard dosing and 67 given EID, revealed no significant differences in patterns of brain damage. Those results indicate that both dosing strategies can reduce disease activity.
In another poster, researchers used data from the TOUCH Prescribing Program to assess the effect of standard dosing or EID on the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection often associated with Tysabri treatment.
Their poster, titled “Natalizumab Extended Interval Dosing (EID) is Associated with a Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) Compared with Every-4-week (Q4W) Dosing: Updated Analysis of the TOUCH Prescribing Program Database,” included data for 15,843 people given Tysabri via standard dosing, and 3,068 receiving EID.
Overall, the mean number of Tysabri infusions and the duration of treatment were greater with EID than with standard dosing. But the risk of PML was significantly reduced with EID — ranging from a 63% to a 96% reduction, depending on the time of EID use.
An ongoing Phase 3b clinical trial, called NOVA (NCT03689972) is currently comparing the effectiveness of standard versus EID Tysabri in patients who were on this treatment for at least one year prior to enrolling. This trial “will help to answer the question of whether the effectiveness of [Tysabri] is maintained with EID,” the researchers wrote in their poster.
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